An Exploratory, Prospective Phase II Study to Investigate Progression-Free Survival, Response and Overall Survival Seen With Pemetrexed/Cisplatin and the Role of Thymidylate Synthase Expression
18 Years
N/A
Both
Non-Small Cell Lung Cancer
Trial Information
An Exploratory, Prospective Phase II Study to Investigate Progression-Free Survival, Response and Overall Survival Seen With Pemetrexed/Cisplatin and the Role of Thymidylate Synthase Expression
All patients on this study will receive 4 intravenous injections of the chemotherapy drugs
pemetrexed and cisplatin (with each injection approximately 3 weeks apart). Patients who
complete 4 such injections and respond well to their treatment may continue to receive an
injection of chemotherapy drug pemetrexed (approximately every 3 weeks). In general terms,
treatment will last until either the patient or the doctor decides that there is no clear
benefit in continuing with the treatment.
TS levels will be measured from the tumour sample used to make the original diagnosis of
NSCLC.
Inclusion Criteria:
- Patients must have Stage 3B or 4 Non-Small Cell Lung Cancer of the non- squamous
type
- Patients must at least be able to be physically mobile, take care of yourself and be
able to perform light activities such as light housework or office work
- Patients must not have had previous chemotherapy treatment for lung cancer
- Patients must not have had radiotherapy in the last 30 days
- Patients must have measureable tumor lesions according to the Response Evaluation
Criteria in Solid Tumors (RECIST) guidelines or disease that can be evaluated on
computed tomography (CT) scan
- Patients' test results assessing the function of their blood forming tissue, kidneys,
liver and lungs are satisfactory
- Women must be sterile, postmenopausal or on contraception and men must be sterile or
on contraception
Exclusion Criteria:
- Patients cannot have received other investigational drugs within the last 30 days
- Patients cannot have any serious, uncontrolled medical condition that might
compromise their ability to take part in the study safely
- Patients cannot have a current second primary malignant tumor
- Patients cannot be having current treatment with any other anti-tumor therapy
- Patients cannot have had a yellow fever vaccination within 30 days of enrolment
- Patients who are unable to take vitamins (including injections of vitamin B12) or
oral cortisone medication
- Patients who are unable to stop taking more than 1.3 grams of aspirin on a daily
basis or non-steroidal anti-inflammatory agents
- Patients who are pregnant or breastfeeding
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression Free Survival (PFS)
Outcome Description:
PFS is time from first dose to first observation of disease progression/death (any cause). PFS is reported for participants with thymidylate synthase (TS) scores. For participants not known to have died by the data cut-off date and who do not have progressive disease, PFS will be censored at date of last objective progression-free disease assessment. For participants who receive systemic anticancer therapy after study drug discontinuation and prior to disease progression/death, PFS will be censored at date of last objective progression-free disease assessment prior to chemotherapy.
Outcome Time Frame:
Baseline to measured progressive disease with follow-up every 6 weeks until progression of disease (up to 18 months after the last participant commenced induction therapy)
Safety Issue:
No
Principal Investigator
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST)
Investigator Role:
Study Director
Investigator Affiliation:
Eli Lilly and Company
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
13069
NCT ID:
NCT00887549
Start Date:
April 2009
Completion Date:
June 2011
Related Keywords:
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|
